Registration of influenza vaccines for children in Europe.

Current trivalent inactivated influenza vaccines (TIV) for seasonal use have all been licensed in the EU based on serological data only. European Medicines Agency (EMA) guidelines for development of influenza vaccines and acceptance criteria are in place for adults but not for children. The Paediatric Committee initiated a review of the literature on influenza vaccines for children, which led to the conclusion that for new influenza vaccines the Paediatric Investigation Plan (PIP) will need to include an efficacy trial.